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NCT00709202 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain
A Phase 2 study, sponsored by Nathan Kline Institute for Psychiatric Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT00709202 is a Phase 2 study that has completed, run by Nathan Kline Institute for Psychiatric Research. The registered enrollment target is 48 participants.
The verdict
NCT00709202, a Phase 2 study, has completed, sponsored by Nathan Kline Institute for Psychiatric Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
The study attempts to evaluate a histamine analog long used for the treatment of Meniere's disease, betahistine, that shows promise in reversing the antihistaminergic effects thought to be involved in antipsychotic induced weight gain. Hypothesis to be tested: A. Patients who have gained a developmentally inappropriate amount of weight on antipsychotics (AP) will see their weight and BMI decrease with betahistine augmentation as compared to placebo augmentation. B. Betahistine augmentation in AP treated patients will increase levels of satiety in a standardized meal situation and decrease caloric intake as compared to placebo augmentation. C. Metabolic effects of betahistine augmentation in AP treated patients will be reflected in differences in waist circumference, hip circumference and waist hip ratios D. Betahistine augmentation in this population will lead to decrease in fasting glucose-lipid lab values related to the development of metabolic syndrome as compared to placebo augmentation
Interventions
- DRUG Placebo Oral Tablet
- DRUG Betahistine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2008-07 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00709202
The ClinicalTrials.gov registry entry for NCT00709202 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nathan Kline Institute for Psychiatric Research, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT00709202 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00709202 about?
NCT00709202 is a clinical study titled "Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain". The study attempts to evaluate a histamine analog long used for the treatment of Meniere's disease, betahistine, that shows promise in reversing the antihistaminergic effects thought to be involved in antipsychotic induced weight gain. Hypothesis to be tested: A. Patients who have gained a develop...
What is the current status of trial NCT00709202?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2008-07. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00709202?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Betahistine (DRUG).
Who is sponsoring clinical trial NCT00709202?
This trial is sponsored by Nathan Kline Institute for Psychiatric Research, which has 20 total clinical trials registered on ClinicalTrials.gov.
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